Varenicline for Long-term Nicotine Replacement Therapy (NRT) Users. A Double Blind, Placebo Controlled Trial
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Primary result is percent not using NRT and not smoking at 12 weeks (point prevalence last 7 days) verified by self-declaration combined with a CO < 8 ppm and a p-cotinine < 15 ng/ml
Study Overview
Brief Summary
Primary aim: Will varenicline be better than placebo to get long-term users of NRT to stop?
Secondary aim: To assess in details some side effects of varenicline i.e. nausea and abnormal dreams.
Detailed Description
100-200 long-term users of NRT will be enrolled in a placebo, controlled, randomized trial with varenicline or placebo for 12 weeks to stop the use of NRT.
Assessments consist of carbon monoxide in expired air, p-cotinine, body-weight, questions about craving, nausea and dreams. Primary result is percent not using NRT and not smoking at 12 weeks (point prevalence last 7 days) and secondary result is not smoking and not using NRT at 12 months. Secondary aims, is a more detailed assessment of nausea and dreams; well-known side effects of varenicline and secondary results are a qualitative description of nausea and dreams.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Long-term, daily NRT users (except nicotine patch) (>11 months) ex-smokers that are willing to try to stop the use of NRT and adhere to this protocol.
- •More than 4 pieces of nicotine gum/ sublingual tablets/ lozenges/ per day, OR more than 3 inhaler cylinders per day, OR
- •more than 10 puffs of nasal spray per day.
Exclusion Criteria
- •Age < 18 years,
- •CO Smokers,
- •Pregnant and lactating women,
- •Used varenicline before,
- •Not able to cooperate,
- •Other significant diseases that might influence the trial (such as moderate -severe cardiac disease, lung cancer,) in expired air > 7 ppm.
Arms & Interventions
varenicline
Varenicline for 12 weeks.
The treatment schedule for varenicline is:
Varenicline tablets, 0.5 mg x 1 daily, day 1-3 Varenicline 0.5 mg x 2, day 4-6 Varenicline 1 mg x 2, day 7 up to 12 weeks
Intervention: support and visits (Behavioral)
varenicline
Varenicline for 12 weeks.
The treatment schedule for varenicline is:
Varenicline tablets, 0.5 mg x 1 daily, day 1-3 Varenicline 0.5 mg x 2, day 4-6 Varenicline 1 mg x 2, day 7 up to 12 weeks
Intervention: varenicline (Drug)
placebo
Placebo for 12 weeks
Intervention: support and visits (Behavioral)
placebo
Placebo for 12 weeks
Intervention: placebo (Drug)
Outcomes
Primary Outcomes
Primary result is percent not using NRT and not smoking at 12 weeks (point prevalence last 7 days) verified by self-declaration combined with a CO < 8 ppm and a p-cotinine < 15 ng/ml
Time Frame: 12 weeks +/- 1 week
Secondary Outcomes
- is not smoking and not using NRT at 12 months (point prevalence last 7 days) verified by self-declaration combined with a CO < 8 ppm and a p-cotinine < 15 ng/ml(12 months +/- 3 weeks)